ASCENSION MODULAR RADIAL HEAD— 510(k) K032686

Name: FDA 510(k) clearance K032686
Creator: U.S. Food and Drug Administration
Published: 2003-10-22

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K032686 for ASCENSION MODULAR RADIAL HEAD, Substantially Equivalent on 2003-10-22. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2003-08-29
Decision date: 2003-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWI

view all

K260624 — Arthrex Radial Head Replacement System2026-07-30
K233592 — BioPoly Radial Head Implant2024-03-13
K231188 — ALIGN Radial Head System2023-09-28
K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17

More clearances from Ascension Orthopedics, Inc.

view all

K233674 — Freedom Wrist Arthroplasty System2024-05-30
K233670 — Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM2013-02-13
K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM2011-12-06
K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.